NCT05161403

Brief Summary

This study aims to evaluate the effect of hyaluronic acid and honey compared to saline in healing of multiple extraction sockets of primary teeth in a group of children aging from Two to Seven years old.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 17, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

February 22, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2023

Completed
Last Updated

December 17, 2021

Status Verified

November 1, 2021

Enrollment Period

1.5 years

First QC Date

October 26, 2021

Last Update Submit

December 3, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Wound healing size in length and width

    There is only one outcome (wound healing) • Multiple measurements (Digital caliper, color, palpation, presence of pus, gingival margin status). 1. Digital caliper: a device used to calculate the size of the socket (width and length) buccolingual in mesiodistal with measurement of mm. 2. Color: normal (pinkish gingiva) Up normal (reddish gingiva) 3. Palpation: if there is bleeding or not. 4. Presence of pus: yes or no 5. Gingival margin: epithelization (yes or no)

    After one week will be calculated the size (lentgh and width) of socket

Study Arms (3)

Hyaluronic acid.

ACTIVE COMPARATOR

1mm layer of hyaluronic acid on a piece of gauze will be applied directly to the sockets wound for 45 minutes at baseline and on the third \& seventh day after extraction of teeth.

Drug: Hyaluronic acidDietary Supplement: honey

Honey

ACTIVE COMPARATOR

1mm layer of Honey on a piece of gauze will be applied directly to the sockets wound for 45 minutes at baseline and on the third \& seventh day after extraction of teeth.

Drug: Hyaluronic acidDietary Supplement: honey

Saline

PLACEBO COMPARATOR

a piece of gauze moistened with normal saline will be applied directly to the sockets wound for 45 minutes at baseline and on the third \& seventh day after extraction of teeth.

Drug: Hyaluronic acidDietary Supplement: honey

Interventions

Wound healing is still a clinical challenge especially in patients who undergo several tooth extractions under general anesthesia or those undergoing major surgeries or those with systemic conditions that disrupt the wound healing process. use of this natural substance is a simple and cost-effective technique and is easily tolerated by children.

HoneyHyaluronic acid.Saline
honeyDIETARY_SUPPLEMENT

Wound healing is still a clinical challenge especially in patients who undergo several tooth extractions under general anesthesia or those undergoing major surgeries or those with systemic conditions that disrupt the wound healing process. Use of this natural substance is a simple and cost-effective technique and is easily tolerated by children.

HoneyHyaluronic acid.Saline

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age: from Two to Seven years old age.
  • Both genders.
  • Children with badly decayed multiple primary teeth beyond repair.
  • Treated under general anesthesia.

You may not qualify if:

  • History of systemic disease.
  • Allergy to honey.
  • Repeatedly used honey during the previous 6 month period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Naaman R, El-Housseiny AA, Alamoudi N, Helal N, Sahhaf R. Reliability and Validity of the Arabic Version of a Questionnaire Assessing Pain, Discomfort and Related Jaw Function Impairment after Extraction of Primary Teeth in Children. Dent J (Basel). 2020 Oct 19;8(4):120. doi: 10.3390/dj8040120.

  • Iacopetti I, Perazzi A, Martinello T, Gemignani F, Patruno M. Hyaluronic acid, Manuka honey and Acemannan gel: Wound-specific applications for skin lesions. Res Vet Sci. 2020 Apr;129:82-89. doi: 10.1016/j.rvsc.2020.01.009. Epub 2020 Jan 11.

  • Maria de Souza G, Elias GM, Pereira de Andrade PF, Andrade Sales KN, Galvao EL, Moreira Falci SG. The Effectiveness of Hyaluronic Acid in Controlling Pain, Edema, and Trismus After Extraction of Third Molars: Systematic Review and Meta-Analysis. J Oral Maxillofac Surg. 2020 Dec;78(12):2154.e1-2154.e12. doi: 10.1016/j.joms.2020.07.005. Epub 2020 Jul 14.

  • Mokhtari S, Sanati I, Abdolahy S, Hosseini Z. Evaluation of the effect of honey on the healing of tooth extraction wounds in 4- to 9-year-old children. Niger J Clin Pract. 2019 Oct;22(10):1328-1334. doi: 10.4103/njcp.njcp_102_19.

  • Jaffe HW, Sweeney HM, Weinstein RA, Kabins SA, Nathan C, Cohen S. Structural and phenotypic varieties of gentamicin resistance plasmids in hospital strains of Staphylococcus aureus and coagulase-negative staphylococci. Antimicrob Agents Chemother. 1982 May;21(5):773-9. doi: 10.1128/AAC.21.5.773.

MeSH Terms

Interventions

Hyaluronic AcidHoney

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Anas M.gassan Raima, master's

CONTACT

Sherine Badr Youness, Associate Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Neither the operator nor the patients could be blinded due to the nature of the study, but the statistician will be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Clinical Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 26, 2021

First Posted

December 17, 2021

Study Start

February 22, 2022

Primary Completion

September 4, 2023

Study Completion

September 4, 2023

Last Updated

December 17, 2021

Record last verified: 2021-11